Post-Trial Responsibilities

Focus Area: Ethical Frameworks

Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a subject’s participation has ended. This may include access to study medications and/or health care and infrastructure for study participants or entire communities for a specific time or lifelong.

Law, policy, and guidance in this area are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions.

Current status: Published ethical framework; dissemination

Impact:

Bringing the clinical trial community towards a practical interpretation of the Declaration of Helsinki’s paragraph 34 that addresses post-trial access responsibilities